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Clinical Trial to Evaluate the Efficacy and Safety of Naftopidil in Male Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

NCT ID: NCT01922375

Last Updated: 2013-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

411 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-09-30

Brief Summary

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This study is designed to evaluate the efficacy and safety of Naftopidil in Korean male patients with with lower urinary tract symptoms associated with benign prostatic hyperplasia.

The investigators hypothesized that Naftopidil which came onto marcket in Japan would effect in improvement of voiding and storage difficulty.

Design:

Placebo-controlled, Randomized, Double-blind, Double-dummy, Parallel group, Fixed dose design

Detailed Description

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Conditions

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Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Naftopidil dose 2

PO administration

Group Type EXPERIMENTAL

Naftopidil

Intervention Type DRUG

Placebo

PO administration

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Naftopidil dose 1

PO administration

Group Type EXPERIMENTAL

Naftopidil

Intervention Type DRUG

Interventions

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Naftopidil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male patients aged 4 years or more diagnosed with BPH

Exclusion Criteria

* subjects with uncontrolled blood pressure
* subjects with hepatic or renal dysfunction
* subjects with prostate cancer
* Had treatments for BPH using other alpha receptor antagonists within 2 weeks
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Dong-A Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sae-Woong Kim, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Jae-Seok Hyun, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

Gyeongsang National University Hospital

Du-Geon Moon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Nam-Cheol Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Hospital

Sung-Won Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Soo-Woong Kim, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Tai-Young Ahn, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Ki-Hak Moon, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

Yeongnam University Hospital

Woo-Sik Chung, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Ewha Womans University Hospital

Kweon-Sik Min, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Inje University

Jong Kwan Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Dae Yul Yang Yang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kangdong Sacred Heart Hospital

Ji- Kan Ryu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Inha University Hospital

Locations

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Chonnam national university hospital

Gwangju, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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FLV_BPH_IV-1

Identifier Type: -

Identifier Source: org_study_id